—#127002

Product

BAG 9732315 MOUSE STERILE 15 PK

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K001284, K012937, K022074, K033621, K871247, K990214
Affected lot / code info: Lot No.: 5246110712 5316560113

Why it was recalled

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-04-24
Posted by FDA: 2014-05-09
Terminated: 2014-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.